Bioprocess Engineer

Asahi Kasei•Fremont, CA

97d•$80,000 - $90,000•Onsite

About The Position

The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment. Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings. Company Summary: Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Position Summary: The Manufacturing Bioprocess Engineer – Downstream is a front-line Subject Matter Expert (SME) responsible for the operational execution of Bionova’s downstream bioprocesses, including chromatography, filtration (depth, TFF, virus filtration), and formulation activities. This role ensures consistent delivery of GMP-compliant drug substance through deviation ownership, process troubleshooting, and continuous improvement. The BPS works closely with manufacturing staff and cross-functional teams to mature Bionova’s purification processes and drive reliable supply.

Requirements

BA/BS in Biological Science, Biotechnology, or Biochemical Engineering with 4 years’ experience in upstream pharmaceutical manufacturing; OR MS with 2 years’ experience in GMP upstream operations.
Hands-on experience with purification unit operations (chromatography, filtration, UF/DF).
Knowledge of process automation platforms (e.g., Unicorn, DeltaV).
Familiarity with biochemical principles underlying protein purification.
Knowledge of process automation and single-use technologies.
Familiarity with scientific principles driving biologics production.
Strong deviation ownership, CAPA development, and technical writing skills.
Ability to troubleshoot complex downstream issues and coach others effectively.
Strong problem-solving and facilitation skills.
Experience in training/mentoring operators in GMP downstream processes.
Project management or Operational Excellence/Six Sigma background.

Responsibilities

Act as SME for downstream operations (column packing, chromatography, UF/DF, filtration, pooling, and formulation).
Provide technical guidance and floor support for real-time issue resolution.
Monitor process data and control parameters to ensure consistent product quality.
Material management and coordination with Supply Chain.
Investigate, manage, and own downstream-related deviations in the Quality Management System.
Perform root cause analysis and implement effective CAPAs.
Manage downstream-related change controls and ensure successful implementation.
Develop and deliver training on chromatography, filtration, and purification workflows.
Mentor operators on column packing techniques, skid operation, and GMP compliance.
Ensure robust documentation of training activities.
Support MSAT with technology transfer.
Identify and implement process improvements to increase yield, robustness, and efficiency in downstream operations.
Apply Lean/Six Sigma tools to optimize workflows and reduce variability.
Author, revise, and review downstream SOPs, Electronic batch records, and work instructions.
Ensure readiness for audits by maintaining GMP compliance across upstream operations.